Urinary Incontinence Clinical Trial
Official title:
A Clinical Investigation to Collect Real-life Measurement Data to Allow Development of Mathematical Algorithms for the Updated TENA SmartCare Change Indicator.
Verified date | March 2024 |
Source | Essity Hygiene and Health AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is an explorative, open, single-arm clinical investigation to collect real-life measurement data in order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator.
Status | Completed |
Enrollment | 13 |
Est. completion date | February 28, 2024 |
Est. primary completion date | December 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Be willing and able to provide informed consent to participate or, if unable to provide such consent, have a legal representative who is willing and able to provide informed consent on behalf of the resident. - Be 18 years of age of older. - Be cared for at the investigation site. - Suffer from urinary incontinence. - Be current user of TENA Slip, Flex, Pants or Comfort incontinence products or during the course of the study be willing to become user of TENA Slip Flex, Pants or Comfort incontinence products. - If applicable, be on a stable regimen of medications for urinary incontinence. Exclusion Criteria: - Have frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator. - Have severe incontinence product related skin problems, as defined by the GLOBIAD categorization 2B (skin loss & infection). - Have any type of indwelling or external urinary catheter(s). - Be anuric. - Be of childbearing potential as determined by the investigator. - Be managed using another automated or digital health technology incontinence management device. - Have responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical. - Have any other condition that makes participation in the clinical investigation - Have a life expectancy of less than 90 days or be in receipt of palliative/terminal care. - Have participated in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the clinical investigation. - Be dependent on either alcohol or recreational drugs. |
Country | Name | City | State |
---|---|---|---|
Sweden | Tre Stiftelser Änggårdsbacken | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Essity Hygiene and Health AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine weight | Absorbing hygiene products used by the subjects are collected in the investigation and the urine weight is determined. The urine weight is then matched with the data measured by the sensor to obtain connect sensor raw data with a specific urine content of an absorbing hygiene products | 15 days | |
Secondary | Number of safety related events | Reported adverse events and device deficiencies are collected during the study. | 15 days | |
Secondary | Caregiver assessment on urine saturation | At the collection of the used absorbing hygiene products the caregiver assess the urine content of the product. This is done by indicating on a 3-point scale if the product change was 1. early, 2. in time or 3. late. | 15 days | |
Secondary | Caregiver usability for sensor | Using a questionnaire at the end of the study data on the caregivers user experience with the sensor is collected using a 5-grade Likert scale were 1 is minimum and 5 maximum and 5 represents the better outcome. | 15 days | |
Secondary | Resident satisfaction with sensor | Using a questionnaire at the end of the study data on the residents satisfaction with the sensor is collected using a 5-grade Likert scale were 1 is minimum and 5 maximum and 5 represents the better outcome. | 15 days |
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